Offc Action Outgoing

United States Patent and Trademark Office (USPTO)

Office Action (Official Letter) About Applicant’s Trademark Application

 

 

 

NONFINAL OFFICE ACTION

 

The USPTO must receive applicant’s response to this letter within six months of the issue date below or the application will be abandoned.  Respond using the Trademark Electronic Application System (TEAS).  A link to the appropriate TEAS response form appears at the end of this Office action. 

 

 

Issue date:  November 06, 2019

 The referenced application has been reviewed by the assigned trademark examining attorney.  Applicant must respond timely and completely to the issue(s) below.  15 U.S.C. §1062(b); 37 C.F.R. §§2.62(a), 2.65(a); TMEP §§711, 718.03.

 

SEARCH OF OFFICE’S DATABASE OF MARKS

 

The trademark examining attorney has searched the USPTO’s database of registered and pending marks and has found no similar registered marks that would bar registration under Trademark Act Section 2(d).  TMEP §704.02; see 15 U.S.C. §1052(d).  However, a mark in a prior-filed pending application may present a bar to registration of applicant’s mark.

 

SUMMARY OF ISSUES:

• Prior-Filed Application
• CBD-Related Goods – No Bona Fide Intent To Lawfully Use In Commerce
• FDCA Refusal – No Bona Fide Intent To Lawfully Use In Commerce
• Identification Of Goods – Amendment Required
• Information About Goods Required
• Foreign Registration Certificate Required

 

PRIOR-FILED APPLICATION

 

The filing date of pending U.S. Application Serial No. 79218713 (CARDIOL) precedes applicant’s filing date.  See attached referenced application.  If the mark in the referenced application registers, applicant’s mark may be refused registration under Trademark Act Section 2(d) because of a likelihood of confusion between the two marks.  See 15 U.S.C. §1052(d); 37 C.F.R. §2.83; TMEP §§1208 et seq.  Therefore, upon receipt of applicant’s response to this Office action, action on this application may be suspended pending final disposition of the earlier-filed referenced application.

 

In response to this Office action, applicant may present arguments in support of registration by addressing the issue of the potential conflict between applicant’s mark and the mark in the referenced application.  Applicant’s election not to submit arguments at this time in no way limits applicant’s right to address this issue later if a refusal under Section 2(d) issues.

 

CBD-RELATED GOODS – NO BONA FIDE INTENT TO LAWFULLY USE IN COMMERCE

 

Registration is refused because applicant does not have a bona fide intent to lawfully use the applied-for mark in commerce. Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; see TMEP §907. 

 

To qualify for federal trademark/service mark registration, the use of a mark in commerce must be lawful.  Gray v. Daffy Dan’s Bargaintown, 823 F.2d 522, 526, 3 USPQ2d 1306, 1308 (Fed. Cir. 1987) (stating that “[a] valid application cannot be filed at all for registration of a mark without ‘lawful use in commerce’”); TMEP §907; see In re Stellar Int’l, Inc., 159 USPQ 48, 50-51 (TTAB 1968); Coahoma Chemical Co., Inc. v. Smith, 113 USPQ 413 (Com’r Pat. & Trademarks 1957) (concluding that “use of a mark in connection with unlawful shipments in interstate commerce is not use of a mark in commerce which the [Office] may recognize.”).  Thus, the goods and/or services to which the mark is applied must comply with all applicable federal laws.  See In re Brown, 119 USPQ2d 1350, 1351 (TTAB 2016) (citing In re Midwest Tennis & Track Co., 29 USPQ2d 1386, 1386 n.2 (TTAB 1993) (noting that “[i]t is settled that the Trademark Act’s requirement of ‘use in commerce,’ means a ‘lawful use in commerce’”)); In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976); TMEP §907. 

 

Here, the items or activities to which the proposed mark are applied were unlawful under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971. The evidence of record indicates that at least some of the items or activities to which the proposed mark may be applied are unlawful under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971.  See attached evidence from http://www.cardiolrx.com/.

 

As evidenced by the indicate applicant’s website, the goods within the scope of the identification bearing the mark contain cannabidiol. Cannabidiol (CBD) is a nonpsychoactive constituent of the cannabis plant.  Applicant’s identified goods and/or services are broad enough to include products produced from “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin” (subject to certain exceptions). 21 U.S.C. §802(16)(definition of “marihuana” – commonly referred to as “marijuana”).

 

In order for an application to have a valid basis that could properly result in a registration, the use of the mark has to be lawful.  See In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976)  Because use of the applied-for mark in connection with such goods and/or services was not lawful as of the filing date, applicant did not have a bona fide intent to lawfully use the applied-for mark in commerce in connection with such goods and/or services.  See In re JJ206, LLC, 120 USPQ2d 1568, 1569 (TTAB 2016) (“where the identified goods are illegal under the federal Controlled Substances Act (CSA), the applicant cannot use its mark in lawful commerce, and ‘it is a legal impossibility’ for the applicant to have the requisite bona fide intent to use the mark.”); see also In re Brown, 119 USPQ2d, 1351-1352; TMEP §907.   

 

On December 20, 2018, the CSA was amended to remove “hemp” from the definition of marijuana and specifically exclude “tetrahydrocannabinols in hemp (as defined under section 297A of the Agricultural Marketing Act of 1946)” from Schedule I, 21 U.S.C. §812(c)(17). Because the identified goods and/or services that feature cannabidiol consist of or include items or activities that are still prohibited under the Controlled Substances Act, namely those containing cannabidiol derived from marijuana, the applicant did not have a valid filing basis for any such items or activities.  To the extent the applicant’s goods are derived solely from cannabis plants that meet the current statutory definition of hemp, such goods may be lawful.

 

Therefore, in order to overcome this refusal, applicant must amend the identification of goods and services to specify that all cannabidiol-containing items are “solely derived from hemp with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.”  Please see the complete requirement for an acceptable identification of goods and/or services below.

 

The applicant may also present arguments and evidence against this refusal. 

 

Applicant should note the following additional ground for refusal.

 

FDCA REFUSAL – NO BONA FIDE INTENT TO LAWFULLY USE IN COMMERCE

 

Registration is refused because applicant does not have a bona fide intent to lawfully use the applied-for mark in commerce.  Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; see TMEP §907. 

 

This refusal issues when “(1) a violation of federal law is indicated by the application record or other evidence, such as when a court or a federal agency responsible for overseeing activity in which the applicant is involved, and which activity is relevant to its application, has issued a finding of noncompliance under the relevant statute or regulation, or (2) when the applicant’s application-relevant activities involve a per se violation of a federal law.”  In re Brown, 119 USPQ2d at 1351 (citing Kellogg Co. v. New Generation Foods Inc., 6 USPQ2d 2045, 2047 (TTAB 1988); Santinine Societa v. P.A.B. Produits, 209 USPQ 958, 964 (TTAB 1981)); TMEP §907.

 

The application identifies items or activities that involve a per se violation of federal law.  See In re Brown, 119 USPQ2d at 1352. The Federal Food, Drug, and Cosmetic Act prohibits the introduction or delivery for introduction into interstate commerce of a food or beverage to which has been added a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.  21 U.S.C. §331(ll); see also 21 U.S.C. §321(ff) (indicating that a dietary supplement is deemed to be a food within the meaning of the Federal Food, Drug and Cosmetic Act). 

 

Cannabidiol (CBD) is an active ingredient in an FDA-approved drug, Epidiolex®, (see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm copy attached) and is the subject of substantial clinical investigations before it was marketed in foods or as dietary supplements. See FDA Regulation of Cannabis and Cannabis-derived Products: Questions and Answers http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm copy attached. The Drug Enforcement Administration (DEA) placed Epidiolex® on schedule V of the CSA on September 27, 2018.  Nevertheless, marijuana and CBD derived from marijuana remain unlawful.  No other cannabis-derived drug products have been approved by the FDA.  Under the Food, Drug and Cosmetics Act (FDCA), any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.  21 U.S.C. § 321(g)(1).

 

In the present case, the application identifies the following goods and/or services for which applicant has alleged a bona fide intent to use in commerce: therapeutic products, namely, pharmaceutical preparations sold by prescription, and including pharmaceutical preparations containing cannabinoids.

 

It is unlawful to introduce food or beverages containing added CBD into interstate commerce or to market CBD as, or in, dietary supplements, regardless of whether the substances are hemp-derived.  See Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm copy attached.  In addition, an unapproved new drug cannot be distributed or sold in interstate commerce unless it is the subject of an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA). 21 U.S.C. §§ 331(d) and 355(a), (b), & (j); see also FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers http://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers copy attached.

 

In order for an application to have a valid basis that could properly result in a registration, the use of the mark has to be lawful.  See In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976)  Because introduction of such goods into commerce was not lawful as of the filing date, applicant did not have a bona fide intent to lawfully use the applied-for mark in commerce in connection with such goods and/or the identified services.  See e.g. In re JJ206, LLC, 120 USPQ2d 1568, 1569 (TTAB 2016) (“where the identified goods are illegal under the federal Controlled Substances Act (CSA), the applicant cannot use its mark in lawful commerce, and ‘it is a legal impossibility’ for the applicant to have the requisite bona fide intent to use the mark.”); see also In re Brown, 119 USPQ2d, 1351-1352; TMEP §907.   

 

Although applicant’s mark has been refused registration, applicant may respond to the refusal(s) by submitting evidence and arguments in support of registration. However, if applicant responds to the refusal(s), applicant must also respond to the requirement(s) set forth below.

 

IDENTIFICATION OF GOODS

 

The identification of goods is indefinite and must be clarified because it is unclear the function and/or purpose of the applicant’s pharmaceutical preparations.  See 37 C.F.R. §2.32(a)(6); TMEP §1402.01.  Applicant may adopt the following identification, if accurate:

 

“Therapeutic products, namely, pharmaceutical preparations, and pharmaceutical preparations containing cannabinoids for {specify disease or condition to be prevented or treated or the health goal to be achieved} whether sold-over-the-counter or by prescription; all of the foregoing containing CBD derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis.”

 

Applicant’s goods and/or services may be clarified or limited, but may not be expanded beyond those originally itemized in the application or as acceptably amended.  See 37 C.F.R. §2.71(a); TMEP §1402.06.  Applicant may clarify or limit the identification by inserting qualifying language or deleting items to result in a more specific identification; however, applicant may not substitute different goods and/or services or add goods and/or services not found or encompassed by those in the original application or as acceptably amended.  See TMEP §1402.06(a)-(b).  The scope of the goods and/or services sets the outer limit for any changes to the identification and is generally determined by the ordinary meaning of the wording in the identification.  TMEP §§1402.06(b), 1402.07(a)-(b).  Any acceptable changes to the goods and/or services will further limit scope, and once goods and/or services are deleted, they are not permitted to be reinserted. TMEP §1402.07(e).

 

For assistance with identifying and classifying goods and services in trademark applications, please see the USPTO’s online searchable U.S. Acceptable Identification of Goods and Services Manual.  See TMEP §1402.04.

 

INFORMATION ABOUT GOODS REQUIRED

 

To permit proper examination of the application, applicant must submit a written statement indicating whether all the goods and/or services identified in the application comply with the Controlled Substances Act (CSA), 21 U.S.C. §§801-971 (see questions below). See 37 C.F.R. §2.69; TMEP §907. The CSA prohibits, among other things, manufacturing, distributing, dispensing, or possessing certain controlled substances, including marijuana and marijuana-based preparations. 21 U.S.C. §§812, 841(a)(1), 844(a); see also 21 U.S.C. §8 02(16) (defining “[marijuana]”). The CSA also makes it unlawful to sell, offer for sale, or use any facility of interstate commerce to transport drug paraphernalia, i.e., “any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under [the CSA].” 21 U.S.C. §863.

 

The requested information should include fact sheets, instruction manuals, brochures, and/or advertisements. If these materials are unavailable, applicant should submit similar documentation for goods and/or services of the same type, explaining how its own product or services will differ.  If the goods and/or services feature new technology and no information regarding competing goods and/or services is available, applicant must provide a detailed factual description of the goods and/or services.

 

Factual information about the goods and/or services must clearly indicate what the goods and/or services are and how they are rendered, their salient features, and their prospective customers and channels of trade. Conclusory statements will not satisfy this requirement for information.

 

In addition, applicant must answer the questions below:

 

1. Do or will the goods include cannabidiol (CBD)?

 

2. If so, will there be more than a trace amount of CBD in the goods, e.g., more than 50 parts per million (PPM)?

 

3. If applicant has any documentation relative to the CBD content of the oils, extracts or derivatives used or to be used in the goods, please submit them with the response.

 

4. Do or will any of applicant’s identified goods include or contain hemp seed oil?

 

5. Which part or parts of the hemp plant are used in obtaining the oils, extracts, ingredients or derivatives?

 

6. Do or will applicant’s identified goods include CBD which is derived from, oils, extracts or ingredients from plants other than Cannabis sativa L (also known as hemp, marijuana or cannabis)?

 

7. Is applicant currently seeking FDA approval of the marketing of its goods identified in the application?

 

8. If the answer to Question 7 is “yes,” please provide a copy of such application.

 

Failure to comply with a request for information is grounds for refusing registration.  In re Harley, 119 USPQ2d 1755, 1757-58 (TTAB 2016); TMEP §814.  Merely stating that information about the goods and services is available on applicant’s website is an insufficient response and will not make the relevant information of record.  See In re Planalytics, Inc., 70 USPQ2d 1453, 1457-58 (TTAB 2004).

 

FOREIGN REGISTRATION CERTIFICATE REQUIRED

 

The application specifies both an intent to use basis under Trademark Act Section 1(b) and a claim of priority under Section 44(d) based on a foreign application.  See 15 U.S.C. §§1051(b), 1126(d); 37 C.F.R. §2.34(a)(2), (a)(4).  However, no copy of a foreign registration has been provided even though the application indicates applicant’s intent to rely on Section 44(e) as an additional basis for registration.  See 15 U.S.C. §1126(e).

 

An application with a Section 44(e) basis must include a true copy, photocopy, certification, or certified copy of a foreign registration from an applicant’s country of origin.  15 U.S.C. §1126(e); 37 C.F.R. §2.34(a)(3)(ii); TMEP §§1004, 1004.01, 1016.  In addition, an applicant’s country of origin must be a party to a convention or treaty relating to trademarks to which the United States is also a party, or must extend reciprocal registration rights to nationals of the United States by law.  15 U.S.C. §1126(b); TMEP §§1002.01, 1004.

 

Therefore, applicant must provide a copy of the foreign registration from applicant’s country of origin when it becomes available.  TMEP §1003.04(a).  A copy of a foreign registration must consist of a document issued to an applicant by, or certified by, the intellectual property office in applicant’s country of origin.  TMEP §1004.01.  If applicant’s country of origin does not issue registrations or Madrid Protocol certificates of extension of protection, applicant may submit a copy of the Madrid Protocol international registration that shows that protection of the international registration has been extended to applicant’s country of origin.  TMEP §1016.  In addition, applicant must also provide an English translation if the foreign registration is not written in English.  37 C.F.R. §2.34(a)(3)(ii); TMEP §1004.01(a)-(b).  The translation should be signed by the translator.  TMEP §1004.01(b).

 

If the foreign registration has not yet issued, or applicant requires additional time to procure a copy of the foreign registration (and English translation, as appropriate), applicant should so inform the trademark examining attorney and request that the U.S. application be suspended until a copy of the foreign registration is available.  TMEP §§716.02(b), 1003.04(b).

 

If applicant cannot satisfy the requirements of a Section 44(e) basis, applicant may request that the mark be approved for publication based solely on the Section 1(b) basis.  See 15 U.S.C. §§1051(b), 1126(e); 37 C.F.R. §2.35(b)(1); TMEP §§806.02(f), 806.04(b), 1003.04(b).  Although the mark may be approved for publication on the Section 1(b) basis, it will not register until an acceptable allegation of use has been filed.  See 15 U.S.C. §1051(c)-(d); 37 C.F.R. §§2.76, 2.88; TMEP §1103.  Please note that, if the U.S. application satisfied the requirements of Section 44(d) as of the U.S. application filing date, applicant may retain the priority filing date under Section 44(d) without perfecting the Section 44(e) basis, provided there is a continuing valid basis for registration.  See 37 C.F.R. §2.35(b)(3)-(4); TMEP §§806.02(f), 806.04(b). 

 

Alternatively, applicant has the option to amend the application to rely solely on the Section 44(e) basis and request deletion of the Section 1(b) basis.  See 37 C.F.R. §2.35(b)(1); TMEP §806.04.  The foreign registration alone may serve as the basis for obtaining a U.S. registration.  See 37 C.F.R. §2.34(a)(3); TMEP §806.01(d).

 

RESPONSE GUIDELINES 

 

Please call or email the assigned trademark examining attorney with questions about this Office action.  Although the trademark examining attorney cannot provide legal advice or statements about applicant’s rights, the trademark examining attorney can provide applicant with additional explanation about the refusal(s) and/or requirement(s) in this Office action.  See TMEP §§705.02, 709.06.  Although the USPTO does not accept emails as responses to Office actions, emails can be used for informal communications and will be included in the application record.  See 37 C.F.R. §§2.62(c), 2.191; TMEP §§304.01-.02, 709.04-.05. 

 

TEAS PLUS OR TEAS REDUCED FEE (TEAS RF) APPLICANTS – TO MAINTAIN LOWER FEE, ADDITIONAL REQUIREMENTS MUST BE MET, INCLUDING SUBMITTING DOCUMENTS ONLINE:  Applicants who filed their application online using the lower-fee TEAS Plus or TEAS RF application form must (1) file certain documents online using TEAS, including responses to Office actions (see TMEP §§819.02(b), 820.02(b) for a complete list of these documents); (2) maintain a valid e-mail correspondence address; and (3) agree to receive correspondence from the USPTO by e-mail throughout the prosecution of the application.  See 37 C.F.R. §§2.22(b), 2.23(b); TMEP §§819, 820.  TEAS Plus or TEAS RF applicants who do not meet these requirements must submit an additional processing fee of $125 per class of goods and/or services.  37 C.F.R. §§2.6(a)(1)(v), 2.22(c), 2.23(c); TMEP §§819.04, 820.04.  However, in certain situations, TEAS Plus or TEAS RF applicants may respond to an Office action by authorizing an examiner’s amendment by telephone or e-mail without incurring this additional fee.  

 

 

How to respond.  Click to file a response to this nonfinal Office action  

 

 

/L. Dantzler/

Lauren A. Dantzler

Examining Attorney

Law Office 122

(571) 272-7348

lauren.dantzler@uspto.gov

 

 

RESPONSE GUIDANCE

• Missing the response deadline to this letter will cause the application to abandon.  A response or notice of appeal must be received by the USPTO before midnight Eastern Time of the last day of the response period.  TEAS and ESTTA maintenance or unforeseen circumstances could affect an applicant’s ability to timely respond.  

 

• Responses signed by an unauthorized party are not accepted and can cause the application to abandon.  If applicant does not have an attorney, the response must be signed by the individual applicant, all joint applicants, or someone with legal authority to bind a juristic applicant.  If applicant has an attorney, the response must be signed by the attorney.

 

• If needed, find contact information for the supervisor of the office or unit listed in the signature block.

 

United States Patent and Trademark Office (USPTO)

 

USPTO OFFICIAL NOTICE

 

Office Action (Official Letter) has issued

on November 06, 2019 for

U.S. Trademark Application Serial No. 88318355

 

Your trademark application has been reviewed by a trademark examining attorney.  As part of that review, the assigned attorney has issued an official letter that you must respond to by the specified deadline or your application will be abandoned.  Please follow the steps below.

 

(1)  Read the official letter.

 

(2)  Direct questions about the contents of the Office action to the assigned attorney below. 

 

 

/L. Dantzler/

Lauren A. Dantzler

Examining Attorney

Law Office 122

(571) 272-7348

lauren.dantzler@uspto.gov

 

Direct questions about navigating USPTO electronic forms, the USPTO website, the application process, the status of your application, and/or whether there are outstanding deadlines or documents related to your file to the Trademark Assistance Center (TAC).

 

(3)  Respond within 6 months (or earlier, if required in the Office action) from November 06, 2019, using the Trademark Electronic Application System (TEAS).  The response must be received by the USPTO before midnight Eastern Time of the last day of the response period.  See the Office action for more information about how to respond.

 

 

 

GENERAL GUIDANCE

·         Check the status of your application periodically in the Trademark Status & Document Retrieval (TSDR) database to avoid missing critical deadlines.

 

·         Update your correspondence email address, if needed, to ensure you receive important USPTO notices about your application.

 

·         Beware of misleading notices sent by private companies about your application.  Private companies not associated with the USPTO use public information available in trademark registrations to mail and email trademark-related offers and notices – most of which require fees.  All official USPTO correspondence will only be emailed from the domain “@uspto.gov.”